AbbVie Bioresearch CenterBiologics Purification Development (Operation Science and Technology)

AbbVie Bioresearch CenterBiologics Purification Development (Operation Science and Technology)• Currently leading a group of purification development scientists supporting IND-enabling process development of AbbVie’s biologics pipeline, including mAbs, DVDs, bispecifics, and antibody fragments. • Led a cross-functional technical team which advanced a pre-clinical biologics asset from host transfection to IND authorship under a highly accelerated timeline. As the lead, I guided the team through process development, clone selection, pilot and GMP scale-up, viral clearance study design/execution, and IND preparations. The team employed numerous acceleration strategies to overcome challenges and meet timelines.• Demonstrated agility and broad project bandwidth, coordinating purification activities for approximately 5-8 pre-clinical programs per year. • Managerial experience of direct reports ranging from associate to senior scientist level, driving their personal growth and motivating high performance.• Driving technology and CMC strategy innovation including pioneering new risk assessment workflows for process-related impurity clearance (presented AbbVie’s strategy at BPI Boston in 2022 and at BPDG37 conference in March 2023).

AbbVie Bioresearch CenterBiologics Purification Development (Operation Science and Technology)• Special assignment and development opportunity within Biologics Purification Process Development.• Designed and conducted purification process characterization studies (ex. chromatography resin aging, scale-down model qualification, impurity clearance justification) to support a supplemental BLA submission for a key AbbVie biologics asset. Established high proficiency in purification unit operations and scale-up: depth filtration, chromatography (affinity, anion/cation exchange, etc.) using AKTA systems, viral filtration, and tangential-flow filtration. • Authored regulatory source documents and reviewed BLA filing sections.

Operations Science and Technology - API• Leader of a cross-functional CMC team that implemented a major post-approval change (API process improvement via a Prior Approval Supplement submission) for a commercial product. I guided the team through lab process development, process scale-up, validation at the commercial site, authorship of regulatory documents, and agency responses. Process improvement resulted in a multimillion-dollar annual savings, and the team was recognized with an AbbVie Operations President’s Award.• Co-lead on a challenging tech transfer of a late-stage API asset to an overseas commercial facility. Challenges included overcoming inherent chemical instability, removal of elemental impurities, and design of an isolation and drying process for a complex hydrated crystal form landscape. • Managed/mentored contractor and intern employees.

Process R&D (Development Sciences)• Served as the lead engineer for the development of the final API synthetic step (chemical reaction, crystallization, and isolation), taking the process from Phase II development through validation, NDA submission, and commercialization. This product is currently on-market and a key AbbVie asset. • Demonstrated predictable scale-up of crystallization and drying processes from gram scale to 100+ kilogram scale by combining experimental and modelling (ex. Dynochem, CFD, and statistical modelling via JMP software) approaches.• Led the technology transfer of the API reaction, crystallization, and isolation process from a chemical pilot plant to an overseas AbbVie commercial facility through collaboration with colleagues in AbbVie Manufacturing Operations. • Designed and conducted experiments (DOE, one factor at a time, and modeling-based) to define the control strategy for critical quality attributes of a late-stage API in preparation for process validation. Authored regulatory source documents and reviewed NDA filing sections.

Completed a Ph.D. in Chemical Engineering under Prof. Chaitan Khosla. Thesis work resulted in 6 first/co-author peer-reviewed publications in high-impact journals.• Devised and conducted experiments to enhance understanding of the fundamental enzymology involved in the biosynthesis of the antibiotic, erythromycin. • Designed, constructed, and validated an in-vitro system to produce erythromycin precursor molecules using purified enzymes. The system allowed for unprecedented analysis of the biosynthetic machinery. • Developed and analyzed strategies for the production of novel erythromycin precursor analogs; these strategies are aimed at producing new antimicrobial therapeutic agents. • Khosla Lab Manager (2012-2014): Responsible for supervising daily activities of 15 lab members: assigning daily lab jobs, overseeing lab instrument purchases and repairs, resolving general lab or interpersonal conflicts.

Completed an Undergraduate Honors Thesis in Chemical Engineering under Prof. Arvind Varma• Studied the kinetics, catalyst optimization, and the reactor design involved in producing the valuable chemical dihydroxyacetone by catalytic oxidation of glycerol (a byproduct of biodiesel fuel production)

Supply chain and materials inventory management intern.